Overview

The marketing authorisation for Lextemy has been withdrawn at the request of the marketing-authorisation holder.

Lextemy : EPAR - Medicine overview

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Product information

Lextemy : EPAR - Product Information

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This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

Lextemy : EPAR - All authorised presentations

English (EN) (588.96 KB - PDF)View
български (BG) (652.99 KB - PDF)
español (ES) (588.36 KB - PDF)
čeština (CS) (642.07 KB - PDF)
dansk (DA) (591.92 KB - PDF)
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eesti keel (ET) (587.73 KB - PDF)
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hrvatski (HR) (621.04 KB - PDF)
íslenska (IS) (589.72 KB - PDF)
italiano (IT) (591.56 KB - PDF)
latviešu valoda (LV) (640.4 KB - PDF)
lietuvių kalba (LT) (624.27 KB - PDF)
magyar (HU) (620.83 KB - PDF)
Malti (MT) (643.86 KB - PDF)
Nederlands (NL) (590.31 KB - PDF)
norsk (NO) (590.2 KB - PDF)
polski (PL) (643.12 KB - PDF)
português (PT) (591.84 KB - PDF)
română (RO) (623.67 KB - PDF)
slovenčina (SK) (643.6 KB - PDF)
slovenščina (SL) (619.65 KB - PDF)
Suomi (FI) (589.93 KB - PDF)
svenska (SV) (590.45 KB - PDF)

Product details

Name of medicine
Lextemy
Active substance
bevacizumab
International non-proprietary name (INN) or common name
bevacizumab
Therapeutic area (MeSH)
  • Colorectal Neoplasms
  • Breast Neoplasms
  • Ovarian Neoplasms
  • Fallopian Tube Neoplasms
  • Peritoneal Neoplasms
  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma, Renal Cell
  • Uterine Cervical Neoplasms
Anatomical therapeutic chemical (ATC) code
L01XC07

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Treatment of carcinoma of the colon or rectum, breast cancer, non-small cell lung cancer, renal cell cancer, epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix.

Authorisation details

EMA product number
EMEA/H/C/005611

Biosimilar

This is a biosimilar medicine, which is a biological medicine highly similar to another already approved biological medicine called the ‘reference medicine’. For more information, see Biosimilar medicines.

Marketing authorisation holder
Mylan IRE Healthcare Limited

Unit 35/36 Grange Parade
Baldoyle Industrial Estate
Dublin 13
Ireland

Opinion adopted
25/02/2021

Assessment history

CHMP summary of positive opinion for Lextemy

English (EN) (684.97 KB - PDF)View

Lextemy : EPAR - Public assessment report

English (EN) (7.07 MB - PDF)View
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